Description

This Webinar will highlight the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA.

This Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the â€œdraftâ€ offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDAâ€™s current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.

Areas Covered in the Seminar:

- Review proposed changes to the 2011 released draft guidance.
- Clarification on definition of sponsor.
- Understand FDA's clear actions that can and will be taken regarding refuse to file a marketing application.
- Time period covered by regulations.